title: Prednisone in COPD exacerbation requiring ventilatory support: an open-label randomised evaluation.
abstract: Recommendation of the use of systemic steroids in chronic obstructive disease (COPD) exacerbation rely on trials that excluded patients requiring ventilatory support. In an open-label, randomised evaluation of oral prednisone administration, 217 patients with acute COPD exacerbation requiring ventilatory support were randomised (with stratification on the type of ventilation) to usual care (n=106) or to receive a daily dose of prednisone (1 mg·kg(-1)) for up to 10 days (n=111). There was no difference regarding the primary end-point, intensive care unit mortality, which was 17 (15.3%) deaths versus 15 (14%) deaths in the steroid-treated and control groups, respectively (relative risk 1.08, 95% CI 0.6-2.05). Analysis according to ventilation modalities showed similar mortality rates. Noninvasive ventilation failed in 15.7% and 12.7% (relative risk 1.25, 95% CI 0.56-2.8; p=0.59), respectively. Both study groups had similar median mechanical ventilation duration and intensive care unit length of stay, which were 6 (interquartile range 6-12) days versus 6 (3.8-12) days and 9 (6-14) days versus 8 (6-14) days, respectively. Hyperglycaemic episodes requiring initiation or alteration of current insulin doses occurred in 55 (49.5%) patients versus 35 (33%) patients in the prednisone and control groups, respectively (relative risk 1.5, 95% CI 1.08-2.08; p=0.015). Prednisone did not improve intensive care unit mortality or patient-centred outcomes in the selected subgroup of COPD patients with severe exacerbation but significantly increased the risk of hyperglycaemia.
authors.affiliation: Fattouma Bourguiba, University Hospital, Monastir.
authors.forename: Fekri
authors.initials: F
authors.lastname: Abroug
authors.forename: Lamia
authors.initials: L
authors.lastname: Ouanes-Besbes
authors.forename: Mohamed
authors.initials: M
authors.lastname: Fkih-Hassen
authors.forename: Islem
authors.initials: I
authors.lastname: Ouanes
authors.forename: Samia
authors.initials: S
authors.lastname: Ayed
authors.forename: Fahmi
authors.initials: F
authors.lastname: Dachraoui
authors.forename: Laurent
authors.initials: L
authors.lastname: Brochard
authors.forename: Souheil
authors.initials: S
authors.lastname: Elatrous
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D018450:Disease Progression; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000150:complications / Q000175:diagnosis; D000860:Hypoxia / Q000150:complications; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage*; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000401:mortality*; D012121:Respiration, Artificial; D012129:Respiratory Function Tests; D012306:Risk; D012907:Smoking; D013997:Time Factors; D016896:Treatment Outcome; D014416:Tunisia
chemical_list: D000893:Anti-Inflammatory Agents; D011241:Prednisone